Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96847993 | 9684799 | 3 | F | 201308 | 20160715 | 20131112 | 20160722 | EXP | PHHY2013BR125769 | NOVARTIS | 53.63 | YR | F | Y | 55.00000 | KG | 20160722 | OT | BR | BR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96847993 | 9684799 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0679 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 96847993 | 9684799 | 2 | C | Q10 | 2 | Oral | 3 U, QD | 0 | 3 | DF | QD | ||||||||
| 96847993 | 9684799 | 3 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | Oral | 1 MG, TID | 0 | 1 | MG | TID | |||||||
| 96847993 | 9684799 | 4 | C | SINVASTAMED | 2 | Unknown | 0 | ||||||||||||
| 96847993 | 9684799 | 5 | C | SINVASTAMED | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 96847993 | 9684799 | 1 | Multiple sclerosis |
| 96847993 | 9684799 | 2 | Product used for unknown indication |
| 96847993 | 9684799 | 3 | Multiple sclerosis |
| 96847993 | 9684799 | 4 | Blood cholesterol abnormal |
| 96847993 | 9684799 | 5 | Blood triglycerides abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 96847993 | 9684799 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 96847993 | 9684799 | Balance disorder | |
| 96847993 | 9684799 | Cognitive disorder | |
| 96847993 | 9684799 | Confusional state | |
| 96847993 | 9684799 | Dysgraphia | |
| 96847993 | 9684799 | Dysphonia | |
| 96847993 | 9684799 | Effusion | |
| 96847993 | 9684799 | Facial asymmetry | |
| 96847993 | 9684799 | Fatigue | |
| 96847993 | 9684799 | Gait disturbance | |
| 96847993 | 9684799 | Haemorrhagic stroke | |
| 96847993 | 9684799 | Ischaemic stroke | |
| 96847993 | 9684799 | Limb discomfort | |
| 96847993 | 9684799 | Memory impairment | |
| 96847993 | 9684799 | Speech disorder | |
| 96847993 | 9684799 | Stress | |
| 96847993 | 9684799 | Thyroid disorder | |
| 96847993 | 9684799 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 96847993 | 9684799 | 1 | 201308 | 0 | ||
| 96847993 | 9684799 | 2 | 20090129 | 0 | ||
| 96847993 | 9684799 | 3 | 20090129 | 0 |